WO2016144073A1 - Dispositif de mesure d'informations biométriques - Google Patents

Dispositif de mesure d'informations biométriques Download PDF

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Publication number
WO2016144073A1
WO2016144073A1 PCT/KR2016/002256 KR2016002256W WO2016144073A1 WO 2016144073 A1 WO2016144073 A1 WO 2016144073A1 KR 2016002256 W KR2016002256 W KR 2016002256W WO 2016144073 A1 WO2016144073 A1 WO 2016144073A1
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WO
WIPO (PCT)
Prior art keywords
electrode
conductive polymer
organic material
biocompatible organic
space
Prior art date
Application number
PCT/KR2016/002256
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English (en)
Korean (ko)
Inventor
조성제
김광복
조재걸
조철호
최형선
강석진
정선태
Original Assignee
삼성전자 주식회사
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Priority claimed from KR1020150140007A external-priority patent/KR102426531B1/ko
Application filed by 삼성전자 주식회사 filed Critical 삼성전자 주식회사
Priority to CN201680014074.8A priority Critical patent/CN107405116B/zh
Publication of WO2016144073A1 publication Critical patent/WO2016144073A1/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • A61B5/14865Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • A61B2562/125Manufacturing methods specially adapted for producing sensors for in-vivo measurements characterised by the manufacture of electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/01Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021Measuring pressure in heart or blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024Detecting, measuring or recording pulse rate or heart rate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/318Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6824Arm or wrist
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848Needles

Definitions

  • Various embodiments of the present invention relate to a biometric information measuring apparatus.
  • a needle is used to obtain a sample from a living body, detect user biometric information, or inject a medicine into a living body.
  • These needles are mostly used micro needle (micro needle) having a diameter of the millimeter level.
  • blood glucose measuring device such as a blood glucose strip to measure blood glucose (called glucose in blood) several times a day after waking up, before meals, and after meals.
  • glucose in blood blood glucose
  • a blood glucose measurement apparatus needs to collect blood from a finger of a measurer using a lancet every time a blood sugar is to be measured, and measures blood glucose of the collected blood using a strip sensor and a reader.
  • the microneedles are infiltrated into the epidermal or dermal layer of the user for a predetermined time to measure blood glucose through the body fluid present in the epidermal or dermal layer.
  • the device for measuring blood glucose using the microneedle (hereinafter referred to as 'microneedle blood glucose meter') includes a plurality of microneedles disposed on a base substrate, and the plurality of microneedles penetrates to the epidermal or dermal layer of the user, thereby forming an epidermal or dermal layer. It has a structure that measures the blood sugar of the measurer through the body fluid.
  • microneedles protrude from the base substrate and are provided with a base needle made of a material such as silicon and a catalyst and a sensing layer coated on the outer circumference of the base needle.
  • a base needle made of a material such as silicon and a catalyst and a sensing layer coated on the outer circumference of the base needle.
  • the microneedles may fall out of the base substrate and become lodged in the epidermal or dermal layer of the measurer. In this case, the microneedles must be left or removed from the user's epidermis, which may amplify anxiety for the user using the microneedle blood glucose meter.
  • the catalyst or the sensing layer coated with the outer circumference of the base needle may be partially removed from the base needle or not coated in the process of carrying the microneedle or processing.
  • the error range of the blood sugar level of the measurer may be increased or the blood sugar level may not be measured when measuring the blood glucose level through the microneedle.
  • the reliability of the microneedle blood glucose meter is deteriorated.
  • a microneedle-shaped base needle should be implemented on a base substrate, and a conductive layer, a sensing layer, and a coating layer should be laminated on the outer circumference of the base needle.
  • a failure rate thereof may increase.
  • microneedle disposed as the working electrode in the microneedle blood glucose meter and the microneedles disposed on the reference electrode or the counter electrode other than the working electrode the arrangement between them cannot be efficiently arranged.
  • an electrode other than the working electrode and the working electrode for example, a reference electrode or a counter electrode, requires a packaging process that requires assembly thereof.
  • various embodiments of the present invention are to provide a biometric information measuring apparatus that can ensure stability even if the microneedle is dropped in the dermal layer of the measurer.
  • various embodiments of the present invention to provide a biometric information measuring device that can ensure the accurate blood sugar level when measuring the blood glucose level through the microneedle even if the case of the catalyst and the detection layer is removed from the outer periphery of the microneedle do.
  • microneedles are disposed as a working electrode and other electrodes, it is possible to efficiently arrange, and to provide a biometric information measuring apparatus that can facilitate their assembly.
  • Biometric information measuring apparatus the sensor unit; And a needle part protruding from the plurality of openings formed in one surface of the sensor part, the needle part including a plurality of needles penetrating into the body, wherein the needles are formed by an enzyme member reacting with the analyte and the reaction of the enzyme member.
  • the conductive polymer that delivers the electrical signal generated by the mixture may comprise a biocompatible organic material.
  • the bioinformation measuring apparatus when a needle part formed of a plurality of microneedles is left in the epidermal or dermal layer of the measurer by being sprayed from the sensor unit, the stability is ensured as it disappears from the epidermal or dermal layer. can do.
  • the needle part as the needle part is formed in one body with a second member mixed with an enzyme member on the first member of the biocompatibility and the conductive organic material, the needle part may be formed in a molding process or a portable or process process. Even if the peripheral edge is dropped or damaged, the difference in the numerical value of the needle portion before and after the damage is not generated when the needle portion is measured in the biometric information, and accurate biometric information values can be obtained.
  • the needle unit according to various embodiments of the present disclosure may be formed by injecting and molding a first member or a second member in a state in which a sensor unit, specifically, an electrode unit, a substrate, a housing, and a mold unit are stacked, thereby measuring biometric information.
  • a sensor unit specifically, an electrode unit, a substrate, a housing, and a mold unit are stacked.
  • the number of manufacturing processes of the device can be minimized, and reproducibility can be ensured when manufacturing the microneedle.
  • the needle part may be formed by injecting and molding a first member or a second member in a state in which a sensor part, specifically, an electrode part, a substrate, a housing, and a mold part are stacked, and thus, a working electrode and other The electrodes can be disposed efficiently, and their assembly can be facilitated.
  • FIG. 1 is a schematic perspective view of a biometric information measuring apparatus according to various embodiments of the present disclosure.
  • FIG. 2 is an exploded perspective view of a biometric information measuring apparatus according to various embodiments of the present disclosure.
  • FIG. 3 is a schematic cross-sectional view of a biometric information measuring apparatus according to various embodiments of the present disclosure.
  • FIG. 4 is a diagram illustrating a main substrate in a biometric information measuring apparatus according to various embodiments of the present disclosure.
  • 5A to 5D are diagrams illustrating various shapes of a reservoir in a biometric information measuring apparatus according to various embodiments of the present disclosure.
  • FIG. 6 is a view illustrating an electrode unit including two electrodes or three electrodes in a biometric information measuring apparatus according to various embodiments of the present disclosure.
  • FIG. 7 is a perspective view schematically illustrating a manufacturing process of a biometric information measuring apparatus according to various embodiments of the present disclosure.
  • FIG. 8 is a diagram schematically illustrating molding a needle part in a biometric information measuring apparatus according to various embodiments of the present disclosure.
  • FIG. 9 is a diagram illustrating another shape of a needle part in the biometric information measuring apparatus according to various embodiments of the present disclosure.
  • FIG. 10 is a diagram illustrating a state in which a biometric information measuring device is invaded by a dermal layer of a user in the biometric information measuring apparatus according to various embodiments of the present disclosure.
  • FIG. 11 is a diagram schematically illustrating that a biometric information measuring device may be attached to a user's body and may be linked to a biometric information measuring device and an external electronic device, according to an embodiment of the present disclosure.
  • FIG. 12 is a block diagram schematically illustrating a manufacturing process of a biometric information measuring apparatus according to various embodiments of the present disclosure.
  • first component may be referred to as the second component, and similarly, the second component may also be referred to as the first component.
  • the term 'and / or' includes any combination of a plurality of related items or any of a plurality of related items.
  • the electronic device may be any device having a touch panel, and the electronic device may be referred to as a terminal, a mobile terminal, a mobile terminal, a communication terminal, a portable communication terminal, a portable mobile terminal, a display device, or the like.
  • the electronic device may be a smartphone, a mobile phone, a navigation device, a game machine, a TV, a vehicle head unit, a notebook computer, a laptop computer, a tablet computer, a personal media player (PMP), a personal digital assistant (PDA), and the like.
  • the electronic device may be implemented as a pocket size portable communication terminal having a wireless communication function.
  • the electronic device may be a flexible device or a flexible display device.
  • the electronic device may communicate with an external electronic device such as a server or perform a task through interworking with the external electronic device.
  • the electronic device may transmit the image photographed by the camera and / or the location information detected by the sensor unit to the server through a network.
  • Networks include, but are not limited to, mobile or cellular networks, local area networks (LANs), wireless local area networks (WLANs), wide area networks (WANs), the Internet, and small area networks. (Small Area Network: SAN) or the like.
  • FIG. 1 is a schematic perspective view of a biometric information measuring apparatus 100 according to various embodiments of the present disclosure.
  • 2 is an exploded perspective view of the biometric information measuring apparatus 100 according to various embodiments of the present disclosure.
  • 3 is a schematic cross-sectional view of the biometric information measuring apparatus 100 according to various embodiments of the present disclosure.
  • the biometric information measuring apparatus 100 may include a sensor unit 110 and a needle unit 140, and the biometric information measuring apparatus ( The mold part 150 may be further included to form the needle part 140 in the process of manufacturing the 100.
  • the sensor unit 110 may be provided to receive biometric information of a user (H: human) (see FIG. 11) detected through the needle unit 140 and detect various biometric information.
  • the sensor unit 110 may be formed such that the needle unit 140, which will be described later, protrudes from the inside of the sensor unit 110 to one surface of the sensor unit 110. Spaces provided with the base 140I + 140II of the needle unit 140 may be formed inside the sensor unit 110, and the sensor unit may be formed through the base 140I + 140II of the needle unit 140. It may have a structure that is electrically connected to the 110.
  • the needle part 140 (also referred to as a 'needle member') may be formed of a biocompatible organic material 141 in which the enzyme member 142 and the conductive polymer 143 are mixed.
  • the needle part 140 polymerizes the biocompatible organic material 141 in which the enzyme member 142 and the conductive polymer 143 are mixed, and then moves from the inside of the sensor part 110 to one surface of the sensor part 110. It can be molded to protrude.
  • the sensor unit 110 is connected to a circuit unit, for example, a communication module through a connector or the like, so as to transmit or receive biometric information measured from the sensor unit 110 to a separate electronic device, for example, a portable terminal. Can be.
  • information received through the circuit unit may be stored or the stored information may be transmitted to the biometric information measuring apparatus 100.
  • Such an electronic device may include a display module to display biometric information, for example, blood sugar information of a detector, thereby displaying various information, for example, food intake according to blood glucose concentration of the user H (see FIG. 11). Can also be.
  • the electronic device may be provided such that the information detected by the biometric information measuring device 100 is data in real time or by date, or numerically, so that the user (H, FIG. 11) can confirm the data.
  • the sensor unit 110 may include a substrate unit 120 and a housing 130.
  • the substrate unit 120 may be disposed under the housing 130, and the biocompatible organic material 141 or the enzyme member 142 in which the enzyme member 142 and the conductive polymer 143 are mixed may be mixed. Instead, the first space portion 125 may be formed to be filled with the biocompatible organic material 141 mixed with the conductive polymer 143 to be filled and molded.
  • the substrate unit 120 may include a main substrate 121 and electrode units 122 and 123, for example, a first electrode 122 and a second electrode 123.
  • the main substrate 121 may be disposed under the housing 130, and the electrode portions 122 and 123 may be disposed on at least one surface of the main substrate 121.
  • the electrode parts 122 and 123 may include the first electrode 122 and the second electrode 123 disposed above and below the main substrate 121 as in the exemplary embodiment of the present invention.
  • the electrode parts 122 and 123 may be disposed only on the upper portion of the main substrate 121 or only below the main substrate 121.
  • the housing 130 has a second electrode 123 from a lower surface thereof. )
  • the main substrate 121 and the first electrode 122 may be stacked in this order.
  • the base 140I + 140II of the needle part 140 is connected to the first electrode 122 and the second electrode 123, and the conductive polymer 143 included in the needle part 140 is the needle part 140.
  • FIG. 4 is a diagram illustrating a main substrate 121 in the biometric information measuring apparatus 100 according to various embodiments of the present disclosure.
  • 5A to 5D are diagrams illustrating various shapes of the reservoir 126a in the biometric information measuring apparatus 100 according to various embodiments of the present disclosure.
  • the main substrate 121 has a biocompatible organic 141 including an enzyme member 142 and a conductive polymer 143 or a biocompatible organic 141 including a conductive polymer 143.
  • the receiving part 126 may be provided to be molded in the inserted and filled state.
  • the first and second electrodes 122 and 123 described above may be disposed on and below the main substrate 121.
  • the receiving unit 126 may be provided to be connected to the first opening 127 formed on the first electrode 122 and the second opening 128 formed on the second electrode 123.
  • the receiver 126 may be provided with a reservoir 126a (reservoir).
  • the reservoir 126a is formed by the biocompatible organic 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic 141 including the conductive polymer 143. It is a component to buffer the change in volume generated when
  • the reservoir 126a is spaced apart from the second opening 128 to be described later by a predetermined opening in the receiving portion 126 having the same size as the second opening 128, the first opening 127.
  • a predetermined opening in the receiving portion 126 having the same size as the second opening 128, the first opening 127.
  • An example is provided to form a wide space on the side (see FIG. 4).
  • the shape of the reservoir 126a is not limited to this.
  • the reservoir 126a is provided between the first opening 127 and the second opening 128, and the receiving portion 126 itself is larger than the second opening 128, and the first opening 127 is provided. It may be provided to be formed in a size corresponding to the receiving portion 126 (see Figure 5a). Unlike this, the reservoir 126a is provided between the first opening 127 and the second opening 128, and the receiving portion 126 is formed to be larger than the first opening 127 and the second opening 128. It may be possible (5b). In contrast, the reservoir 126a is connected to the upper and lower surfaces of the receiving portion 126 in the same size as the first opening 127 and the second opening 128, and the reservoir 126a is formed of the first opening 127 and the first opening.
  • the reservoir 126a may be disposed between the first opening portion and the second opening portion, and may be provided to protrude in one direction from one side of the receiving portion 126 to form a space (see FIG. 5D).
  • FIG. 6 is a diagram illustrating electrode parts 122 and 123 provided as two electrodes or three electrodes in the biometric information measuring apparatus 100 according to various embodiments of the present disclosure.
  • the electrode parts 122 and 123 are provided on the main substrate 121 and may be mounted on the main substrate 121 to be mounted above and below the main substrate 121.
  • 122 may include a second electrode 123.
  • the electrode parts 122 and 123 according to an embodiment of the present invention may be provided as two electrodes or three electrodes to detect the biometric information signal.
  • the working electrodes WE, 122W and 123W are working electrodes
  • the counter electrodes CE which are provided around the working electrodes WE, 122W and 123W, 122C, 123C (counter electrode)
  • the electrode portion 122, 123 is provided with three electrodes, the working electrode (WE, 122W, 123W) (working electrode), and the working electrode (WE, Counter electrodes CE, 122C, 123C (counter electrode) provided around the periphery of 122W, 123W and the end and neighboring ends of the counter electrodes CE, 122C, 123C around the working electrode WE, 122W, 123W.
  • the reference electrodes RE, 122R, and 123R may be provided as reference electrodes. However, when the electrode parts 122 and 123 are provided as two electrodes, the needle part 140 may be provided to be connected to correspond to the respective positions of the two electrodes. However, in the present invention, the working electrodes WE and 122W may be provided. For example, it may be described that it is formed on the sensor unit 110 so as to be connected to correspond to the 123W. In addition, when the electrode parts 122 and 123 are provided as three electrodes, the needle part 140 may be provided to be connected to correspond to respective positions of the three electrodes. However, in the present invention, the working electrodes WE and 122W may be used. For example, it may be described that it is formed on the sensor unit 110 to be connected to correspond to the 123W.
  • the working electrode W.E is an electrode used to cause a desired reaction, and is also called an operating electrode, a working electrode, or a test electrode.
  • the working electrode WE uses various biometric information such as glucose, lactic acid, body temperature, blood pressure, skin conductivity, heart rate, electrocardiogram, cholesterol, minerals, and the like through the biosignal obtained through the needle unit 140.
  • Disease biomarkers BIO-Marker
  • cytokines Cytokine
  • hormones viruses or virus-derived material, bacteria or bacteria-derived material may be detected and measured.
  • the counter electrode C.E is also referred to as a counter electrode, and is an electrode provided to face the working electrode W.E so as to flow a current in the working electrode W.E.
  • the reference electrode RE is an electrode that is a practical reference for measuring a potential difference. For example, when measuring an electrode potential generated between a solution and a metal, its absolute value cannot be measured. The relative value can be measured in combination with the electrode on the basis of not changing, and is also referred to as a comparison electrode or a reference electrode.
  • the biosignal information signal may be calculated by measuring a current generated by placing a potential difference between the working electrode W.E and the counter electrode C.E.
  • the working electrode WE is provided to measure an electrical signal
  • the counter electrode CE is arranged around the working electrode WE.
  • the reference electrode RE may be provided to supply a reference potential to the working electrode WE toward the end of the counter electrode CE.
  • the first electrode 122 may be provided on one surface of the main substrate 121. It may be electrically connected to the needle part 140.
  • the second electrode 123 may be provided on the other surface of the main substrate 121, and may be provided to be connected to an external connector terminal of the biometric information measuring device 100.
  • the first space portion 125 may be provided in the substrate portion 120 including the main substrate 121 and the first and second electrodes 122 and 123 (see FIGS. 3 and 4).
  • the first space 125 may be provided as an accommodation part 126, a first opening 127, and a second opening 128.
  • the first opening 127, the accommodating part 126, and the second opening 128 are connected to each other.
  • the first space 125 is formed.
  • the first space 125 is filled with the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143, and molded.
  • the first electrode 122 may be formed by the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 filled in the space 125 or the biocompatible organic material 141 including the conductive polymer 143.
  • the second electrode 123 may be provided to be energized.
  • the accommodating part 126 penetrates inside the main substrate 121 to form a space.
  • the accommodating part 126 may be provided in the same shape as the 1st opening part 127 or the 2nd opening part 128 mentioned later.
  • the accommodating part 126 includes the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143. It has been described above that the reservoir 126a may be provided to have a predetermined space for the volume change.
  • the first opening 127 may be formed to penetrate one surface and the other surface of the first electrode 122 and may be provided to correspond to the position of the receiving portion 126.
  • the first opening 127 may be formed to connect the second space 135 and the accommodation portion 126.
  • the first opening 127 is a biocompatibility including the enzyme member 142 and the conductive polymer 143 injected through the second opening 128 and the receiving portion 126 when the biometric information measuring apparatus 100 is manufactured.
  • the biocompatible organic material 141 including the organic material 141 or the conductive polymer 143 may be provided to the second space part 135.
  • the first opening 127 may be provided in pairs at the electrode portions 122 and 123, respectively.
  • two first openings 127 may be formed at the working electrode W.E and two at the counter electrode C.E, respectively.
  • the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143 is injected into the sensor unit 110 to be described later.
  • 140 or when forming the first needle part 140C or the second needle part 140R, which will be described later, one of the first openings 127 provided as a pair is the enzyme member 142 and the conductive polymer 143.
  • the biocompatible organic material 141 or the biocompatible organic material 141 including the conductive polymer 143 may be provided as an inlet 127Wa, 127Ca into which the first opening 127 is provided.
  • the electrode portions 122 and 123 are formed of three electrodes, two first openings 127 are provided on the working electrode WE, two on the counter electrode CE, and two on the reference electrode RE. Each can be formed.
  • the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143 may be injected into the sensor unit 110.
  • one of the first opening portions 127 provided as a pair may include the enzyme member 142 and the conductive polymer 143.
  • the first opening may be provided as a pair of injection holes 127Wa, 127Ca, and 127Ra into which the biocompatible organic material 141 including) or the biocompatible organic material 141 including the conductive polymer 143 is introduced.
  • the other one of the first and second portions 127 may include a biocompatible organic material 141 including an enzyme member 142 and a conductive polymer 143 or a biocompatible organic material 141 including a conductive polymer 143.
  • 125 or the air filled in the second space 135 may be discharged. It may be provided as an outlet (127Wb, 127Cb, 127Rb) of the air.
  • the molded enzyme is formed.
  • the biocompatible organic 141 including the member 142 and the conductive polymer 143 or the biocompatible organic 141 including the conductive polymer 143 may be electrically connected to the first electrode 122.
  • the second opening 128 may be formed on the second electrode 123.
  • the second opening 128 is provided to be connected to the receiving portion 126 to a position corresponding to the receiving portion 126, and includes a biocompatible organic material 141 including an enzyme member 142 and a conductive polymer 143.
  • the biocompatible organic material 141 including the conductive polymer 143 may be injected.
  • the second openings 128 may be provided in pairs at the electrode portions 122 and 123, respectively. For example, when the electrode parts 122 and 123 are formed of two electrodes, two second openings 128 may be formed at the working electrode W.E and two at the counter electrode C.E, respectively.
  • the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143 is injected into the sensor unit 110 to be described later. 140 or when forming the first needle portion 140C or the second needle portion 140R to be described later, one of the second openings 128 provided as a pair is the enzyme member 142 and the conductive polymer 143.
  • the biocompatible organic material 141 including or the biocompatible organic material 141 including the conductive polymer 143 may be provided as an injection hole (128Wa, 128Ca) is introduced, the second opening 128 provided in pairs The other one of the first space portion 125 or when the biocompatible organics 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organics 141 including the conductive polymer 143 is filled The air outlet 1 through which air filled in the second space part 135 may be discharged. 28Wb, 128Cb).
  • the electrode portions 122 and 123 are formed of three electrodes
  • two second openings 128 are provided on the working electrode WE, two on the counter electrode CE, and two on the reference electrode RE. Each can be formed.
  • the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143 may be injected into the sensor unit 110.
  • one of the second openings 128 provided as a pair may include the enzyme member 142 and the conductive polymer 143.
  • the second opening may be provided as a pair of injection holes 128Wa, 128Ca, and 128Ra into which the biocompatible organic material 141 including the or the biocompatible organic material 141 including the conductive polymer 143 is introduced.
  • the other one of the 128 is the first space portion (b) when the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143 is filled.
  • 125 or the air filled in the second space 135 may be discharged. It may be provided with an outlet (128Wb, 128Cb, 128Rb) of the air.
  • the first space portion 125 includes the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143 in the second opening 128. And a biocompatible organic material 141 including a molded enzyme member 142 and a conductive polymer 143 or a biocompatible organic material 141 including a conductive polymer 143 when the second space part 135 is filled and molded. May be electrically connected to the first electrode 122.
  • the enzyme member 142 provided in the needle unit 140 reacts with an analyte in the body, and the information is reacted with the first electrode 122. It is delivered to the second electrode 123, in which the base 140I + 140II of the needle 140 filling the first opening 127 and the base 140 of the needle 140 filling the second opening 128 are formed. 140I + 140II), so that the reaction information of the enzyme member 142 may be transmitted to the electrode portions 122 and 123, respectively.
  • the housing 130 is configured to be stacked on an upper portion of the substrate 120, and may form a second space 135 connected to the first space 125 inside the second housing 120. Through the 135, the needle part 140 or the first needle part 140C or the second needle part 140R, which will be described later, may protrude to one surface of the housing 130.
  • the housing 130 may include a first body 131 and a second body 132.
  • the first body 131 may be referred to as a partition frame, and the second body 132 may be referred to as a fixed frame.
  • the first body 131 may be stacked on the substrate 120, specifically, on the first electrode 122, and form a second space 135 connected to the first space 125.
  • the second body 132 is stacked above the first body 131 and includes a plurality of openings 132a connected to the second space part 135, and the plurality of needle parts 140 may be formed.
  • One body 131 may be provided to be fixed. Accordingly, the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 filled in the second space part 135 or the biocompatible organic material 141 including the conductive polymer 143 is formed in the openings ( It may protrude to one side of the sensor unit 110 through 132a.
  • the plurality of openings 132a provided in the second body 132 need not be provided at the same position or the same number as the needle portion 140.
  • the second body 132 may include a biocompatible organic material 141 including an enzyme member 142 and a conductive polymer 143 filled in the second space part 135, as may be provided as a mesh plate.
  • the biocompatible organic 141 including the conductive polymer 143 may be introduced into the needle tip 151, and the biocompatible organic including the enzyme member 142 and the conductive polymer 143 filled in the needle tip 151. If the biocompatible organic material 141 including the conductive polymer 143 or the conductive polymer 143 is formed through polymerization, the second body may be separated or separated from the second space part 135.
  • the openings 132a provided in the 132 and the second body 132 may be modified or changed as much as possible.
  • the second space part 135 may be divided into two compartments or three compartments according to the configuration of the electrode units 122 and 123. That is, the second space part 135 may be divided into a partition space partitioned into a region corresponding to the position of the working electrode W.E and a region corresponding to an electrode other than the working electrode W.E.
  • the second space part 135 is divided into two compartments, specifically, the first electrode.
  • the partition space 135W and the second compartment space 135C may be separated.
  • the first compartment space 135W is provided to correspond to the position of the working electrode WE, and the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 is disposed on the working electrode WE position. It is a space partitioned so that it can be filled.
  • the second compartment space 135C is adjacent to the first compartment space 135W, and includes a biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 on the counter electrode CE. The space is partitioned so that the biocompatible organic material 141 including the conductive polymer 143 may be filled.
  • the second space part 135 is divided into three compartments.
  • the space may be divided into a first compartment 135W, a second compartment 135C, and a third compartment 135R.
  • the first compartment space 135W is provided to correspond to the position of the working electrode WE and includes the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 on the working electrode WE position.
  • the space is partitioned so that the biocompatible organic material 141 including the conductive polymer 143 may be filled.
  • the second compartment 135C is disposed around the periphery of the first compartment 135W, and includes a biocompatible organic material including the enzyme member 142 and the conductive polymer 143 on the counter electrode CE. 141 or a space partitioned so that the biocompatible organic material 141 including the conductive polymer 143 may be filled.
  • the third compartment space 135R is disposed adjacent to the first compartment space and the second compartment space 135C, for example, on one end side of the second compartment space 135C, and is disposed on the reference electrode RE.
  • the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143 may be filled.
  • the first body 131 may include the needle part 140 through the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143.
  • the components are provided so that the compartments can be divided according to the function of the electrode parts 122 and 123.
  • the second body 132 is provided with a plurality of openings 132a at positions corresponding to the electrode portions 122 and 123, and includes a biocompatible organic material including an enzyme member 142 and a conductive polymer 143.
  • the biocompatible organic material 141 including the 141 or the conductive polymer 143 is introduced through the second space part 135, and then protrudes upward through the opening to be molded, thereby forming each of the electrode parts 122 and 123.
  • the base 140I + 140II of the needle part 140 disposed inside the sensor part 110, for example, the compartment of the second space part 135.
  • the base 140I + 140II of the needle unit 140 provided in the space may be provided to fix or support the base unit 140 and the housing 130 so as not to be separated from the substrate unit 120 and the housing 130.
  • the needle part 140 may be filled from the first space part 125 and the second space part 135 inside the sensor part 110 (hereinafter referred to as “needle part base 140I +). 140II) '), and may be provided to protrude to one surface of the sensor unit 110, for example, the housing 130 (hereinafter referred to as a' micro needle portion 140III ').
  • the needle part 140 protrudes from the sensor part 110 so as to penetrate into the dermal layer H2 of the user H (see FIG. 11), and includes the first and second space parts 125 and 135.
  • the needle portion base 140I + 140II and the microneedle portion 140III that are filled and molded in FIG. 1 may be embodied as a one-body as a whole.
  • the needle portion 140, in particular, the microneedle portion 140III may be a user.
  • Biocompatible organics 141a that penetrate into the skin of H (see FIG. 11), specifically, the dermis layer H2, and may be separated or separated from the sensor unit 110 and remain in the dermis layer H2, but may melt away from the skin. It may be made of a material containing a.
  • the needle part 140 may be implemented with a biocompatible organic material 141 including an enzyme member 142 and a conductive polymer 143, and may include an enzyme member 142 and a conductive polymer 143.
  • the biocompatible organic 141 may be formed by polymerization and molding.
  • the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 is a liquid phase, and is disposed on the rear side of the sensor unit 110 after laminating the mold unit 150 on the sensor unit 110. After injection through the formed opening, the polymerization may form the needle part 140, the first needle part 140C, or the second needle part 140R protruding to one surface from the inside of the sensor part 110. The process of manufacturing the needle part 140, the first needle part 140C, or the second needle part 140R may be described later in detail.
  • the needle part 140 is described, for example, disposed in the working electrode region WEA connected to the working electrode WE, and the material thereof is the enzyme member 142. ) And a biocompatible organic material 141 including a conductive polymer 143.
  • the working electrode WE is configured to detect information generated when the enzyme member 142 reacts with the body fluid, and is disposed on the working electrode WE and the needle part 140 connected to the working electrode WE.
  • the enzyme member 142 should be included.
  • the needle part 140 corresponding to the position of the working electrode WE may include the biocompatible organic material including the biocompatibility 141a and the conductive polymer 143 including the enzyme member 142 in the conductive polymer 143. 141).
  • the first needle part 140C or the second needle part 1410R provided at a position other than the working electrode WE, for example, the counter electrode CE or the reference electrode RE, will be described later.
  • 142 and the conductive polymer 143 may be made of a mixed biocompatible organic 141, the enzyme member 142 may not be mixed and may be provided with a biocompatible organic 141 mixed with the conductive polymer 143. There will be.
  • the needle part 140 provided at the position of the working electrode WE is described as an example in which the biocompatible organic material 141 in which the enzyme member 142 and the conductive polymer 143 are mixed is molded into one body.
  • the needle part 140 which will be described later, is located in the working electrode WE, and the enzyme member 142 is not mixed, but is formed into a body only with the biocompatible organic material 141 in which the conductive polymer 143 is mixed. Coating the biocompatible organic 141 in which the enzyme member 142 or the enzyme member 142 or the conductive polymer 143 is mixed with the outer surface of the molded body formed only of the biocompatible organic 141 in which the polymer 143 is mixed. Needle portion 140 disposed on the working electrode (WE) as it may be provided as long as the configuration is provided with an enzyme member 142 that can react with the reaction material in the body will be possible to modify or change.
  • the first needle part 140C or the second needle part 140R which is disposed on the counter electrode CE or the reference electrode RE, is not required to be reacted with the enzyme member 142 in the body.
  • the microneedles 140III are scattered and remain in the body, they are provided only for the potential difference between the working electrode WE and the like on the counter electrode CE or the reference electrode RE.
  • the first needle part 140C or the second needle part 140R may be formed only of the biocompatibility 141a in which the conductive polymer 143 is mixed.
  • the first needle part 140C or the second needle part 140R disposed on the counter electrode CE or the reference electrode RE includes a biocompatible organic material including an enzyme member 142 and a conductive polymer 143.
  • Electrodes other than the working electrode WE or the working electrode WE may be modified as much as they can be formed as a body by forming the biocompatible organic 141 in which the enzyme member 142 and the conductive polymer 143 are mixed. Or change will be possible.
  • the needle part 140 may be disposed at, for example, a position of an electrode other than the working electrode WE and the working electrode WE, depending on the function of the electrode parts 122 and 123, and, alternatively, the needle part 140 of the present invention. ) Is disposed at the position of the working electrode WE, and the needle portion 140 and the first needle portion 140C or the second needle portion 140R, which are separate from the needle portion 140, are at the position of the electrode other than the working electrode WE. It may be partitioned separately from 140.
  • the needle part 140 may be disposed on the position of the working electrode WE and the counter electrode CE.
  • the needle part 140 may be disposed on the position of), and the first needle part 140C may be disposed on the position of the counter electrode CE.
  • the upper surface of the housing 130 is adjacent to the working electrode area WEA and the working electrode area WEA, which are connected to the working electrode WE.
  • the counter electrode region CEA may be partitioned to a position corresponding to the position of the electrode CE.
  • the needle part (hereinafter referred to as the 'operating needle part 140W') may be provided to protrude from the working electrode area W.E.A.
  • the operation needle part 140W may be connected to the first compartment space 135W on the operation electrode region W.E.A.
  • the operation needle part 140W may be formed of a biocompatible organic material 141 in which the enzyme member 142 and the conductive polymer 143 are mixed to protrude from the inside of the sensor part 110 to one side of the sensor part 110.
  • the entire needle part 140W, that is, the needle part bases 140I and 140II and the microneedle part 140III may be provided as one body.
  • the operating needle part 140W is a molded body of a biocompatible organic material 141 including the conductive polymer 143.
  • the operating needle part 140W is formed of the biocompatibility 141a and the conductive material.
  • the actuating needle part protruding toward the sensor part 110 from the inside of the sensor part 110 is formed by forming the biocompatible organic material 141 including the enzyme member 142 including the polymer 143 f and the conductive polymer 143.
  • 141 may be coated and provided.
  • the first needle part 140C may be provided to protrude from the counter electrode region C.E.A.
  • the first needle part 140C may be connected to the second compartment space 135C on the counter electrode region C.E.A.
  • the first needle part 140C may be formed of the biocompatible organic material 141 in which the enzyme member 142 and the conductive polymer 143 are mixed or the biocompatible organic material 141 in which the conductive polymer 143 is mixed to form the sensor part 110. ) May protrude from the inner side to one side of the sensor unit 110, and the first needle unit 140C may also be provided as a whole body like the needle unit 140 described above.
  • the needle part 140 may be disposed on the working electrode WE, the counter electrode CE, and the reference electrode RE.
  • the needle portion 140 may be disposed on the position of the working electrode WE
  • the first needle portion 140C may be disposed on the position of the counter electrode CE.
  • the second needle part 140R may be disposed in position.
  • the upper surface of the housing 130 may be formed to be formed by a working electrode region WEA connected to the working electrode WE and a peripheral circumference of the working electrode region WEA.
  • a position corresponding to the position of the electrode CE may be adjacent to the counter electrode region CEA and the working electrode region WEA, and may be disposed to be adjacent to one end of the counter electrode region CEA.
  • the reference electrode region REA may be partitioned to correspond to the position of.
  • the operation needle part 140W may be provided to protrude from the operation electrode area W.E.A.
  • the operation needle part 140W may be connected to the first compartment space 135W on the operation electrode region W.E.A.
  • the operation needle part 140W may be formed of a biocompatible organic material 141 in which the enzyme member 142 and the conductive polymer 143 are mixed to protrude from one side of the sensor part 110 to one side of the sensor part 110.
  • the entire needle part 140W may be provided as one body.
  • the operating needle part 140W is a molded body of a biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143.
  • the operating needle part 140W is conductive.
  • the biocompatible organic material 141 mixed with the polymer 143 is formed to protrude from one side of the sensor unit 110 to one side of the sensor unit 110, and an enzyme member 142 or an enzyme member 142 on its outer surface. And a biocompatible organic 141 mixed with the conductive polymer 143 may be coated.
  • the first needle part 140C may be provided to protrude from the counter electrode region C.E.A.
  • the first needle part 140C may be connected to the second compartment space 135C on the counter electrode region C.E.A.
  • the first needle part 140C may be formed of a biocompatible organic material 141 in which the enzyme member 142 and the conductive polymer 143 are mixed to protrude from one side of the sensor part 110 to one side of the sensor part 110.
  • the entire first needle part 140C may be provided as one body.
  • the first needle part 140C is formed of only the biocompatible organic material 141 in which the enzyme member 142 and the conductive polymer 143 are mixed.
  • the enzyme member 142 is not mixed with the conductive polymer ( 143 may be composed of mixed biocompatible organics 141.
  • the second needle part 140R may protrude from the reference electrode area R.E.A.
  • the second needle part 140R may be connected to the third compartment space 135R on the reference electrode region R.E.A.
  • the second needle part 140R may be formed of a biocompatible organic material 141 in which the enzyme member 142 and the conductive polymer 143 are mixed to protrude from one side of the sensor part 110 to one side of the sensor part 110.
  • the entire second needle portion 140R may be provided in one body.
  • the second needle part 140R may be formed of a biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143.
  • the second needle part 140R may be the same as the first needle part 140C.
  • the conductive polymer 143 which is not mixed may be formed of the mixed biocompatible organic material 141.
  • FIG. 7 is a perspective view schematically illustrating a manufacturing process of the biometric information measuring apparatus 100 according to various embodiments of the present disclosure.
  • FIG. 8 is a diagram schematically illustrating molding the needle unit 140 in the biometric information measuring apparatus 100 according to various embodiments of the present disclosure.
  • the needle part 140 is, as mentioned above, inside the sensor part 110, specifically, the first space part 125, the second space part 135, and the sensor part 110. Needles protruding to one side of the) is a component of the body.
  • the needle part 140 may protrude from the plurality of openings 132a formed on one surface of the sensor part 110.
  • the needle part 140 (hereinafter, the needle part 140 collectively refers to all of the operation needle part 140W, the first needle part 140C, and the second needle part 140R) to the sensor part 110 is one body.
  • the mold unit 150 is stacked on top of the sensor unit 110 in which the substrate unit 120 and the housing 130 are stacked, and the enzyme member 142 is formed through the opening of the rear surface of the sensor unit 110.
  • the biocompatible organic 141 including the conductive polymer 143 or the biocompatible organic 141 including the conductive polymer 143, and then polymerized and the needle part 140 provided as a molded body of one body. ) Can be formed.
  • the mold part 150 may be stacked on the housing 130 while the substrate part 120 and the housing 130 are stacked.
  • An inner surface of the mold unit 150 specifically, a surface in which the mold unit 150 and the housing 130 face each other, corresponds to the positions of the electrode units 122 and 123 and may shape the shape of the needle unit 140.
  • a plurality of concave needle tip 151 may be provided to make.
  • the arrangement regions of the needle tip 151 may be divided according to the arrangement of the electrode portions 122 and 123, for example, the second electrode or the third electrode.
  • the mold unit 150 may include the biocompatible organic material 141 or the conductive polymer 143 including the enzyme member 142 and the conductive polymer 143 that are injected through the first space 125 and the second space 135.
  • the biocompatible organic material 141 including) is formed to protrude to one side of the sensor part 110 to form the needle part 140, and then is removed from the sensor part 110.
  • the size of the needle tip 151 may be provided such that the needle part 140 has a size of 30-300 um on the surface of the sensor unit 110, and the height of the needle part 140 is 200-1,000. It may be provided to have a size of um.
  • the mold unit 150 When the mold unit 150 is stacked on the sensor unit 110, the second electrode 123, the main substrate 121, the first electrode 122, the first body 131, the second body 132, and the like.
  • the mold parts 150 are stacked in this order.
  • the sensor unit 110 and the mold unit 150 are stacked as described above, from the second opening 128 provided in the second electrode 123, the receiving unit 126, the first opening 127, and the first opening 127 are formed.
  • the two spaces 135 and the needle tip 151 may be provided so as to be connected to each other.
  • the enzyme when the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143 is injected through the second opening 128, the enzyme
  • the biocompatible organic 141 including the member 142 and the conductive polymer 143 or the biocompatible organic 141 including the conductive polymer 143 includes the receiving portion 126, the first opening 127, and the second opening. It is injected into the space 135 and fills the first space 125 and the second space 135 inside the sensor 110.
  • the living body including the biocompatible organic material 141 or the conductive polymer 143 including the enzyme member 142 and the conductive polymer 143 filling both the first space portion 125 and the second space portion 135.
  • the compatible organic 141 may be injected into the needle tip 151 through the opening of the housing 130.
  • the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143 may include the first space part 125 and the second space part 135. ) And the nitrile tip, and then polymerize the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143 to form the sensor unit 110. ) And a molded body of the needle part 140 protruding from one side of the sensor part 110.
  • the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 in the fluid state or the biocompatible organic material 141 including the conductive polymer 143 may be electropolymerized, thermally polymerized, photopolymerized or acid polymerized. Or at least one of base polymerization.
  • the molded body may be formed by the electropolymerization of the polymerization method to prevent damage to the enzyme member 142 during the polymerization process.
  • the needle part 140 protrudes toward one side of the sensor part 110 while being filled in the inner side of the sensor part 110, the first space part 125 and the second space part 135. It can be provided.
  • the conductive polymer 143 is made of polypyrrole, polyaniline, polyacetylene, polyphenylene and polyphenylene vinylene.
  • (Poly) phenylene vinylene), polythiophene ((Poly) thiophene), polydiacetylene ((Poly) diacetylene), poly 3,4-ethylenedioxythiophene (PEDOT) may be made of a material comprising at least one material. .
  • the conductive polymer 143 included in the needle part 140 may be utilized as a sensor electrode on the surface of the micro needle part 140III, and the conductive polymer 143 may be formed of the micro needle part 140III. It may be provided to be electrically connected between the electrode (122, 123) on the surface.
  • the enzyme member 142 may use a substance to be measured in the biological information and a substance having a selectivity.
  • a filler may be further included in the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143.
  • the material of the filler may be any biocompatible material that does not cause a biomass that occupies a volume.
  • the material of the filler may be poly (lactic acid) (PLA), poly (D, L- It may include at least one of organic materials such as lactic acid (PDLLA), poly (lactic-co-glycolic) (PLGA), poly (ethylene glycol) (PEG), poly (dimethylsiloxane) (PDMS), polycaprolactone.
  • the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143 may include the first space portion 125 and the second space portion 135. ) And when the nipple tip is filled and polymerized, a volume change can occur.
  • the filler is used to control the volume change generated during the polymerization of the biocompatible organic 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic 141 including the conductive polymer 143. It may be added to the biocompatible organic 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic 141 including the conductive polymer 143.
  • the aforementioned reservoir 126 for example, the reservoir 126a formed in the receiver 126, may include a biocompatible organic material including an enzyme member 142 and a conductive polymer 143 filled in the first space 125. Volume change may be controlled in the process of polymerizing the biocompatible organic 141 including the 141 or the conductive polymer 143.
  • FIG. 9 is a diagram illustrating another shape of the needle part 140 in the biometric information measuring apparatus 100 according to various embodiments of the present disclosure.
  • the needle part 140 may be formed of a biocompatible organic material 141 included in the conductive polymer 143 without the enzyme member 142.
  • the first needle part 140C may be formed.
  • the second needle part 140R may be made of only the above material, but the working needle part 140W should be mixed with an enzyme member 142 capable of reacting with the reactant in the body.
  • the enzyme member (3) is formed on the outer surface of the microneedle part 140III formed of the biocompatible organic material 141 included in the conductive polymer 143 protruding to one side of the sensor part 110.
  • 142 or the biocompatible organic 141 mixed with the enzyme member 142 and the conductive polymer 143 may be provided.
  • the portion provided with the microneedle portion 140III coated with the enzyme member 142 may be a couple disposed on the working electrode region W.E.A.
  • the biocompatible organic 141 including the enzyme member 142 or the enzyme member 142 and the conductive polymer 143 may be implemented.
  • FIG. 10 is a diagram illustrating a state in which the biometric information measuring device 100 is invaded by the dermal layer H2 of the user H (see FIG. 11) in the biometric information measuring apparatus 100 according to various embodiments of the present disclosure.
  • FIG. 11 illustrates that the biometric information measuring device 100 is attached to a body of a user H (refer to FIG. 11) in the biometric information measuring device 100 according to various embodiments of the present disclosure.
  • the needle part 140 may be located on the surface of the epidermal layer H1 existing in the outermost layer of the skin of the user H. Referring to FIGS. When the needle part 140 is pressed on the biometric information measuring device 100 with a predetermined force while being disposed on the skin surface, the needles may penetrate into the epidermal layer H1 and the dermal layer H2. In this case, since the nerve is not distributed in the epidermal layer H1 or the dermal layer H2, when the microneedle electrode penetrates only to the dermal layer H2, the test subject will not detect the pain caused by the penetration of the needle.
  • the epidermal layer H1 present in the outermost layer of the skin has the largest impedance, more accurate measurement is possible even if the needles are transmitted only to the epidermal layer H1, but as described above, the needles are applied to the epidermal layer H1.
  • the more accurate measured value can be obtained by penetrating into the dermis layer (H2).
  • the needle is infiltrated into the subcutaneous tissue (H3) under the dermal layer (H2) in order to obtain a more accurate measurement of the biological information, the first stimulation, pain of the nerve by the needle because the needle is very fine , Pain can be very small.
  • the biosignal measured in the subcutaneous tissue (H3) of the living body by applying the biometric information measuring device 100 to the skin may be transmitted to an external electronic device, such as a portable terminal, through needles and electrodes. . .
  • the separate electronic device may store the biometric information transmitted from the biometric information measuring device 100.
  • the biometric information for example, the blood glucose concentration of the user H
  • the biometric information transmitted by the user may be represented by a graph or statistics.
  • the biometric information of the user may be confirmed by various methods such as time or date.
  • the biometric information measuring apparatus 100 may be described.
  • the aforementioned components, functions, operations, and the like may apply mutatis mutandis to the above description.
  • FIG. 12 is a block diagram schematically illustrating a manufacturing process of the biometric information measuring apparatus 100 according to various embodiments of the present disclosure.
  • the biometric information measuring apparatus 100 includes a liquid enzyme member 142 and a conductive polymer 143 in a stacked sensor unit 110.
  • the mixed biocompatible organic 141 or the conductive polymer 143 mixed with the biocompatible organic 141 may be injected and then polymerized and molded to form the needle part 140.
  • the substrate unit 120 includes a first space portion 125 and a second space portion 135 connected to the first space portion 125 on the substrate portion 120.
  • the housing 130 may be stacked (S10).
  • the first body 131 and the second body 132 may be sequentially stacked in the state in which the first electrode 122 is disposed on the main substrate 121.
  • the mold 150 having the shape of the needle tip 151 recessed to the upper portion of the second body 132 may be stacked.
  • the second electrode 123 may be mounted on the lower portion of the main substrate 121 when the first electrode 122 is mounted on the main substrate 121.
  • the second electrode 123 may later be mounted with the second body 132. After stacking to the top of the), the stacked components may be turned upside down and the second electrode 123 may be stacked on the rear surface of the main substrate 121 to correspond to the position of the receiving portion 126.
  • the components stacked in the order of the second electrode 123, the main substrate 121, the first electrode 122, the first body 131, the second body 132, and the mold part 150 are formed.
  • the second opening 128 may be exposed on one surface of the first laminate set.
  • the electrode portions 122 and 123 are provided as two electrodes, the discharge holes 123Wb and 123Cb and the injection holes 123Wa and 123Ca are formed at the position of the working electrode WE and the counter electrode CE of the second electrode 123.
  • Each of the two openings 128 may be exposed to expose four openings.
  • the discharge holes 123Wb, 123Cb, and 123Rb are formed in the working electrode WE, the counter electrode CE, and the reference electrode RE of the second electrode 123.
  • the second openings 128 of the injection holes 123Wa, 123Ca, and 123Rb may be exposed to expose six second openings 128, respectively.
  • the biocompatible organic material including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material including the conductive polymer 143 at a position corresponding to the injection hole among the exposed second openings 128 ( 141 may be injected (S20).
  • the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 is injected into the second opening 128 of the working electrode WE, and an electrode other than the working electrode WE, for example,
  • the enzyme member 142 may be mixed with the second opening 128 of the counter electrode CE or the reference electrode RE, or the conductive polymer 143 may not be mixed with the enzyme member 142.
  • At least one of the mixed biocompatible organics 141 may be injected.
  • the biocompatible organic material 141 including the conductive polymer 143 may be implanted into the working electrode region W.E.A, the counter electrode region C.E.A, and the reference electrode region R.E.A.
  • the biocompatible organic material 141 including the enzyme member 142 or the enzyme member 142 and the conductive polymer 143 on the outer surface of the needle formed at the position of the working electrode region WEA. ) May be provided to be coated.
  • the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143 is injected into the receiving part 126. ) And fills the inside of the second space portion 135 that flows into the second space portion 135 through the first opening 127 to form a partition space in the shape of the electrode portions 122 and 123.
  • the biocompatible organic material 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic material 141 including the conductive polymer 143 may be formed in the second space part 135.
  • the needle tip 151 of the mold 150 may be filled through the plurality of openings of the body 132.
  • the biocompatible organic material including the biocompatible organic material 141 or the conductive polymer 143 including the enzyme member 142 and the conductive polymer 143 filled up to the needle tip 151 of the mold part 150 is filled.
  • 141 may be molded using at least one of electropolymerization, thermal polymerization, photopolymerization, acid polymerization, or basic polymerization (S30).
  • electropolymerization thermal polymerization
  • photopolymerization photopolymerization
  • acid polymerization or basic polymerization (S30).
  • S30 basic polymerization
  • the biocompatible organics 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organics 141 including the conductive polymer 143 are polymerized, they are internally, specifically, inside the sensor unit 110. Needles protruding to one side of the first space portion 125, the second space portion 135, and the sensor portion 110 may be integrally formed (S40).
  • the mold unit 150 may polymerize and remove the biocompatible organic 141 including the enzyme member 142 and the conductive polymer 143 or the biocompatible organic 141 including the conductive polymer 143 ( S50).
  • the mold part 150 may be formed. After removing the biocompatible organic material 141 including the conductive polymer 143 including the enzyme member 142 to the surface of the needle protruding to the working electrode (WE) location to react with the reactants in the body It may be provided to be.
  • the needle part 140 may include the biocompatible organic material 141 or the conductive polymer 143 including the enzyme member 142 and the conductive polymer 143 in the stacked state of the sensor part 110. Since the organic material 141 may be formed by injecting and polymerizing, the manufacturing process is simple and easy. In addition, since the needle part 140 is integrally formed from the space inside the sensor part 110 to the needle protruding to one side of the sensor part 110, the inner side or the outer side of the needle may be provided with the same composition. The same biometric information can always be realized even if the outside is dropped or a defect occurs.
  • the needles formed integrally are made of a biocompatibility 141a material, the needles are melted in the dermal layer H2 when the needles are left in the dermal layer H2 due to invasion in the dermal layer H2. Abandonment may reduce the risk of use.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Optics & Photonics (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

Selon divers modes de réalisation, l'invention concerne un dispositif de mesure d'informations biométriques qui comporte : une unité de capteur ; une unité d'aiguille comprenant une pluralité d'aiguilles qui font saillie par une pluralité d'ouvertures formées sur une surface de l'unité de capteur et qui pénètrent dans le corps, les aiguilles pouvant comprendre une matière organique biocompatible dans laquelle un élément enzymatique, qui réagit avec une substance à analyser, est mélangé avec un polymère conducteur qui fournit un signal électrique généré par la réaction de l'élément enzymatique. De plus, le dispositif de mesure d'informations biométriques de la présente invention peut être mis en œuvre de différentes façons selon les modes de réalisation.
PCT/KR2016/002256 2015-03-06 2016-03-07 Dispositif de mesure d'informations biométriques WO2016144073A1 (fr)

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CN201680014074.8A CN107405116B (zh) 2015-03-06 2016-03-07 生物计量信息测量设备

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US201562129256P 2015-03-06 2015-03-06
US62/129,256 2015-03-06
KR10-2015-0140007 2015-10-05
KR1020150140007A KR102426531B1 (ko) 2015-03-06 2015-10-05 생체 정보 측정 장치 및 이의 제작 방법

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